The North American Neuromodulation Society (NANS) held its mid-year meeting July 15-17 in Orlando, Florida. Among all of the presentations reporting on state-of-the-art neuromodulation devices there was some new data presented on pain stimulators offered by Boston Scientific Corporation of Marlborough, Massachusetts.
The company has been investigating the use of advanced spinal cord stimulation methods in its newer WaveWriter Alpha system, which supports up to 4 leads and 32 contacts and comes with either a rechargeable battery or a long-lived non-rechargeable.
The real breakthrough of the full body MRI conditional system is the mechanism of action of the FAST and Contour stimulation therapies. The company launched the WaveWriter Alpha in the Europe in September 2020, and the U.S. in January 2021.
No Waiting for SCS to Start Working With FAST
At the mid-year NANS meeting, researchers presented a trio of abstracts providing results from recent studies into the stimulation therapies offered by the WaveWriter Alpha. One study investigated the use of fast-acting sub-perception therapy (FAST). This therapy provides paresthesia-free pain relief typically at a frequency of 90 Hz. The data presented at NANS came from a real-world, observational case-series of patients receiving a trial device that provided the FAST treatment with or without simultaneous use of a customized field shape programming algorithm (Contour) for approximately one week.
The study identified that 29 out of 33 (88%) were FAST responders (> 50% pain relief). Responders averaged a 5.8-point NRS score improvement, with pain reduced from 8.2 to 2.4 points on average. This statistically significant improvement is further buoyed by the magnitude of improvement by about half of responders. Of the 29 responders, 16 (55%) had a greater than 80% reduction in pain. Early work and an understanding of the mechanism of action of FAST came from a multi-year collaboration with Prof. Warren Grill, Ph.D., a professor in the Biomedical Engineering department at Duke University.
Why Not Both? Boston Scientific Tests Combination Therapies
The second abstract presented on behalf of Boston Scientific at the NANS mid-year meeting described the one-year outcomes of the COMBO randomized controlled trial. The trial investigated the use of both the Contour therapy, a sub-perception-based customized field shape algorithm, delivered simultaneously with traditional paresthesia-based SCS [spinal cord stimulation] (Combination Therapy) compared with only paresthesia-based SCS therapy alone (Monotherapy).
Investigators found in this randomized clinical trial that after three months there was a responder rate of 88% (pain reduction of at least 50% and no increase in opioid use) in the Combination Therapy group vs 71% in the Monotherapy control group. This rate was consistent after one full year of therapy with an 84% responder rate. Overall satisfaction was very high in the treatment group, with a 90% satisfaction rate at three months. The study also identified a 22-point reduction in ODI (Oswestry Disability Index) and an 81% satisfaction rate for all patients after a full year.
The final abstract revealed results of a two-year, 420-patient, “real world” study of the Spectra WaveWriter providing customized patient therapy with stimulation modalities customized to each patient’s needs. Stimulation options included Combination Therapy and Contour, a novel algorithm for patient-specific stimulation field shape-customization for dorsal horn targeting.
Baseline NRS (numerical rating scale) was reduced from an average of 7.2 by 4.9 points by final follow up. Even with clinically relevant pain relief on average at one year, a substantial proportion of patients reported NRS pain scores under 2 points (61%) or no pain at all (NRS=0;23%). At two-year follow up, response rate remained high at 79% with 65% reporting NRS of <2, 45% >80% pain relief, and 24% reporting no pain (NRS=0). However, only 82/420 (19.5%) of participants were included in the two-year follow-up data.
There’s an App for That
OTW spoke with Boston Scientific’s Vice President of Medical Affairs, Nilesh Patel, M.D., M.B.A., about the studies being presented at the NANS mid-year meeting. Patel expressed his excitement and pointed out that these “response rates are very encouraging for patients suffering from chronic pain.”
In a nod to patient individuality and personalization, new features included with the WaveWriter Alpha provide patients with an app, called mySCS, that allows them set individualized goals and track their progress. Not every patient expects to be completely pain-free or able to run a marathon, but tasks as simple as being able to walk, sleep, stand, or sit with less pain mean significant quality of life improvements.
Walking was found to be among the most common goals of patients using the app. Additionally, with Bluetooth connectivity physicians are able to monitor patient’s treatment and progress toward their goals and adjust in order to give the patient the best pain relief possible.
In a study of 1,253 patients using the mySCS app, Boston Scientific researchers found that patients using the app had a 6-percentage point increase in trial success than those who did not (91% vs 85%) over the three- to seven-day SCS trial period. The WaveWriter Alpha pulse generator is designed with the ability to be updated with new features without additional surgeries to implant newer devices.
SCS Answers a Public Health Concern
Patel concluded our conversation with a message to patients suffering from chronic pain, “With advancing technology, we are able to offer patients new hope in their journey for pain relief. We continuously investigate and test new methods of spinal cord stimulation to provide the best and most customized therapy possible.”
These studies, while relatively small compared to trials of devices offered by competitors, have high responder rates based on standard definitions of >50% pain reduction. Further, the number of patients with even greater pain reduction is impressive and encouraging and suggest that larger studies will continue to show statistical significance. Certainly, the pain management community will be interested to read the full publication of the final results of these studies.
From a public health standpoint, SCS therapy may be exactly what the world needs, especially the U.S., which is struggling with an opioid epidemic. The CDC [Centers for Disease Control and Prevention] recently released a report indicating that overdose deaths reached an all-time high during the COVID-19 pandemic. Psychological and physiological increases in pain during the pandemic have turned countless sufferers to find narcotic pain relief. The need for non-opioid pain relief has never been greater.
